1b9db681-a297-5aa9-e063-6394a90a80ea

SPL v2

SPL

SPL Set ID 1b9db681-a297-5aa9-e063-6394a90a80ea

Route

topical

Published

Effective Date 2024-06-24

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

lidocaine (5 g)

Inactive Ingredients

alcohol glycerin polysorbate 20

Identifiers & Packaging

Marketing Status

otc monograph drug active Since 2024-06-24

Purpose

lieduce pain and swelling during tattouermanent cosmetics,electrolysis other pain sensitive procedures

Description

LIDOCAINE 5%

Medication Information

Warnings

For external use only.

Uses

After cleaning the skin, apply an appropriate amount of gel to the area to be treated.

Massage gently for a few minutes and wait for 15 to 30 minutes for the gel to take effect as an anesthetic.

Purpose

lieduce pain and swelling during tattouermanent cosmetics,electrolysis other pain sensitive procedures

Inactive Ingredients

WATER 36.7%

ALCOHOL 15%

POLYSORBATE 20 3%

GLYCERIN 20%

PROPYLENE GLYCOL 10%

YUCCA GLAUCA ROOT EXTRACT 2%

ACHILLEA MILLEFOLIUM FLOWER EXTRACT 3%

CAPRYLYL GLYCOL 0.3%

DISODIUM EDTA 0.2%

PHENOXYETHA-NOL 0.3%

CARBOMER 3.5%

TRIETHANOLAMINE 1%

Description

LIDOCAINE 5%

Dosage

Squeeze out an appropriate amount of product and spread evenly on skin.

Section 51945-4

Do Not Use

on damaged or broken skin.

Active Ingredients

LIDOCAINE 5%

When Using This Product

keep out of eyes. Rinse with water to remove.

Stop Use and Ask A Doctor If

rash occurs.

Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Structured Label Content

Warnings

For external use only.

Uses

After cleaning the skin, apply an appropriate amount of gel to the area to be treated.

Massage gently for a few minutes and wait for 15 to 30 minutes for the gel to take effect as an anesthetic.

Purpose

lieduce pain and swelling during tattouermanent cosmetics,electrolysis other pain sensitive procedures

Inactive Ingredients (Inactive ingredients)

Dosage

Squeeze out an appropriate amount of product and spread evenly on skin.

Section 51945-4 (51945-4)

Do Not Use (Do not use)

on damaged or broken skin.

Active Ingredients (Active ingredients)

LIDOCAINE 5%

When Using This Product (When using this product)

keep out of eyes. Rinse with water to remove.

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

rash occurs.

Keep Out of Reach of Children. (Keep out of reach of children.)

If swallowed, get medical help or contact a Poison Control Center right away.

Advanced Ingredient Data

[{"name": "ALCOHOL", "unii": "3K9958V90M", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LIDOCAINE", "unii": "98PI200987", "classCode": "ACTIB", "strengthNumerator": "5", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYSORBATE 20", "unii": "7T1F30V5YH", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "After cleaning the skin, apply an appropriate amount of gel to the area to be treated. Massage gently for a few minutes and wait for 15 to 30 minutes for the gel to take effect as an anesthetic.", "Dosage": "Squeeze out an appropriate amount of product and spread evenly on skin.", "Purpose": "lieduce pain and swelling during tattouermanent cosmetics,electrolysis other pain sensitive procedures", "Warnings": "For external use only.", "Do not use": "on damaged or broken skin.", "Active ingredients": "LIDOCAINE 5%", "Inactive ingredients": "WATER 36.7% ALCOHOL 15% POLYSORBATE 20 3% GLYCERIN 20% PROPYLENE GLYCOL 10% YUCCA GLAUCA ROOT EXTRACT 2% ACHILLEA MILLEFOLIUM FLOWER EXTRACT 3% CAPRYLYL GLYCOL 0.3% DISODIUM EDTA 0.2% PHENOXYETHA-NOL 0.3% CARBOMER 3.5% TRIETHANOLAMINE 1%", "When using this product": "keep out of eyes. Rinse with water to remove.", "Stop use and ask a doctor if": "rash occurs.", "Keep out of reach of children.": "If swallowed, get medical help or contact a Poison Control Center right away."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:23.572011 · Updated: 2026-03-14T23:09:09.169888